June 29, 2016
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Karbinal ER

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Karbinal ER

Indications
Dosage
How Supplied

INDICATIONS

Karbinal ER Extended-release Oral Suspension is an H1 receptor antagonist indicated for the symptomatic treatment of:

DOSAGE AND ADMINISTRATION

The dosage of Karbinal ER should be individualized based on the severity of the condition and the response of the patient. Start with lower doses and increase as needed and tolerated.

Administer Karbinal ER by the oral route only. Measure Karbinal ER with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. [see WARNINGS AND PRECAUTIONS]

Adults and Adolescents 12 years of age and older: 7.5 mL to 20 mL (6 to 16 mg) every 12 hours Children 2 to 11 years of age (approximately 0.2 to 0.4 mg/kg/day):

2 to 3 years: 3.75 mL to 5 mL (3 to 4 mg) every 12 hours

4 to 5 years: 3.75 mL to 10 mL (3 to 8 mg) very 12 hours

6 to 11 years: 7.5 mL to 15 mL (6 to 12 mg) every 12 hours

HOW SUPPLIED

Dosage Forms And Strengths

Extended-release oral suspension containing 4 mg carbinoxamine maleate per 5 mL

Storage And Handling

Karbinal ER contains 4 mg carbinoxamine maleate per 5 mL. It is a light beige to tan viscous suspension with strawberry banana flavor and is supplied as follows:

NDC 13551-101-05 Bottles of 16 fl oz (480 mL)
NDC 13551-101-01 Bottles of 1 fl oz (30 mL)

Physician Samples

Store at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Dispense in tight, light-resistant container with child-resistant closure.

Distributed by: Charlotte, NC 28210 www.fsclabs.com.Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852. Revised: Nov 2013

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/15/2015

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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